URIDINE TRIACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159	NDA	BTG International Inc	50633-220-04	4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET	2024-07-31
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159	NDA	BTG International Inc	50633-220-20	20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET	2024-07-31
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169	NDA	BTG International Inc	50633-330-30	30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02)	2024-05-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies key suppliers of uridine triacetate (also known as VISTOGARD® or CUY-1804) for pharmaceutical applications. Uridine triacetate is an orally administered prodrug of uridine used to mitigate the hematologic toxicity of fluoropyrimidine chemotherapy. The analysis focuses on chemical synthesis capabilities, regulatory compliance, and production capacity relevant to the pharmaceutical industry.

What are the Primary Manufacturers of Uridine Triacetate?

Several chemical manufacturers and contract development and manufacturing organizations (CDMOs) are capable of producing uridine triacetate. The primary manufacturers often possess established Good Manufacturing Practice (GMP) compliance and a history of supplying active pharmaceutical ingredients (APIs).

Haider Pharma: This company is a notable supplier of uridine triacetate, specializing in the synthesis of pharmaceutical intermediates and APIs. They offer GMP-grade material suitable for clinical trials and commercial drug production. Haider Pharma emphasizes quality control and regulatory adherence in their manufacturing processes. Their production capacity is scalable to meet commercial demands.
PharmaEssentia Corporation: While primarily known for its finished drug products, PharmaEssentia has been involved in the development and supply chain management of uridine triacetate. Their involvement suggests access to or direct control over manufacturing processes that meet stringent pharmaceutical standards.
Specialty Chemical Manufacturers (Unspecified): A segment of the market is served by specialized chemical synthesis companies that may not be publicly listed as direct API suppliers but can produce uridine triacetate under contract. These entities often operate with high levels of confidentiality, particularly when serving large pharmaceutical clients. Their capabilities range from kilogram to multi-ton scale production, depending on the facility.

What are the Key Capabilities and Certifications of Uridine Triacetate Suppliers?

Suppliers for pharmaceutical-grade uridine triacetate must demonstrate specific capabilities and maintain relevant certifications to ensure product quality, safety, and regulatory compliance.

Manufacturing and Quality Control

GMP Compliance: Manufacturers must operate under current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This includes rigorous process validation, quality assurance, and quality control measures.
Synthetic Route Expertise: The synthesis of uridine triacetate involves multiple chemical steps. Suppliers with a well-established and optimized synthetic route are preferred. This ensures consistent yield, purity, and impurity profiles. Common synthetic strategies often involve acetylation of uridine.
Analytical Capabilities: Comprehensive analytical testing is critical. This includes High-Performance Liquid Chromatography (HPLC) for purity and impurity profiling, Nuclear Magnetic Resonance (NMR) spectroscopy for structural confirmation, Mass Spectrometry (MS) for molecular weight and fragmentation analysis, and Karl Fischer titration for moisture content.
Impurity Profiling: Detailed identification and quantification of process-related impurities and potential degradants are essential. Regulatory filings require a thorough understanding of the impurity profile.

Regulatory and Documentation Support

Drug Master File (DMF) Submission: Suppliers often maintain Drug Master Files with regulatory agencies. A DMF provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own regulatory submissions without having to disclose proprietary manufacturing information.
Certificates of Analysis (CoA): Each batch of uridine triacetate supplied must be accompanied by a Certificate of Analysis detailing the results of all specified quality control tests.
Stability Data: Comprehensive stability studies under various storage conditions are required to establish the shelf life of the API.

Production Scale and Lead Times

Scalability: Suppliers must demonstrate the ability to scale production from laboratory or pilot plant quantities (kilograms) to commercial manufacturing volumes (hundreds of kilograms to metric tons).
Lead Times: Typical lead times for GMP-grade APIs can range from 12 to 24 weeks, depending on the supplier's existing production schedule, raw material availability, and the complexity of the synthesis. Rush orders may incur premium pricing and subject to availability.

What are the Regulatory Considerations for Uridine Triacetate Sourcing?

Sourcing uridine triacetate for pharmaceutical use is subject to significant regulatory oversight to ensure patient safety and drug efficacy.

FDA and EMA Regulations

API Registration: The manufacturing site for the API must be registered with the relevant health authorities. Inspections by these authorities are common to verify GMP compliance.
ICH Guidelines: Suppliers are expected to adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly ICH Q7 for GMP for APIs.
Quality Agreements: A formal Quality Agreement between the API supplier and the drug product manufacturer is mandatory. This agreement outlines the responsibilities of each party regarding quality control, change management, and issue resolution.

Supply Chain Security and Traceability

Auditing Rights: Drug product manufacturers have the right to audit API suppliers to ensure ongoing compliance with quality standards and regulatory requirements.
Change Control: Any significant changes to the manufacturing process, specifications, or analytical methods at the API supplier must be managed through a formal change control process and communicated to the drug product manufacturer in a timely manner.
Country of Origin: The country of origin for the API can impact import regulations and risk assessments. Transparency regarding the manufacturing location is essential.

Who are the Key Contract Development and Manufacturing Organizations (CDMOs) for Uridine Triacetate?

While some companies may manufacture uridine triacetate for their own branded products or as a direct API supplier, many pharmaceutical companies rely on Contract Development and Manufacturing Organizations (CDMOs) for specialized synthesis and GMP production.

Lonza: As a global CDMO, Lonza possesses extensive experience in small molecule API synthesis and GMP manufacturing. They have capabilities to handle complex multi-step syntheses and can scale production to meet commercial demands. Lonza's regulatory track record and quality systems make them a strong candidate for producing pharmaceutical ingredients like uridine triacetate.
Catalent: Catalent offers a broad range of development and manufacturing services for APIs. Their expertise in process development, analytical services, and GMP manufacturing makes them a suitable partner for producing uridine triacetate. They can support projects from early-stage development through to commercial supply.
Thermo Fisher Scientific (Patheon): Through its Patheon brand, Thermo Fisher Scientific provides integrated drug substance development and manufacturing services. They have global facilities equipped for API synthesis and can manage the entire process from clinical trial materials to commercial volumes, adhering to stringent regulatory standards.
WuXi AppTec: This China-based CDMO offers comprehensive R&D and manufacturing services. WuXi AppTec has a significant capacity for small molecule API production under GMP conditions and serves a global pharmaceutical client base. Their integrated services can streamline the development and supply chain for uridine triacetate.

The selection of a CDMO often depends on factors such as specific technical requirements of the synthesis, desired production scale, geographical location, cost, and the CDMO's existing expertise with nucleoside derivatives or similar complex molecules.

What are the Challenges in Sourcing High-Purity Uridine Triacetate?

Sourcing high-purity uridine triacetate can present several challenges for pharmaceutical companies.

Complex Synthesis: The multi-step synthesis of uridine triacetate requires specialized chemical expertise and stringent process control to achieve high purity and to minimize the formation of related impurities, such as incompletely acetylated uridine or other by-products.
Raw Material Variability: The quality and consistency of starting materials, particularly uridine, can impact the final product. Suppliers must have robust qualification processes for their raw material vendors.
Impurity Control: Identifying and controlling specific impurities to meet pharmaceutical specifications (e.g., <0.1% for individual unknown impurities) can be technically demanding. This requires advanced analytical techniques and process optimization.
Regulatory Hurdles: Ensuring that the manufacturing process and facility meet the rigorous GMP standards of agencies like the FDA and EMA adds complexity and cost. Any deviation can lead to regulatory delays or rejections.
Supply Chain Disruptions: Global supply chains for specialized chemicals can be vulnerable to geopolitical events, raw material shortages, or logistical issues. Diversifying suppliers or having strong relationships with existing ones is crucial.
Cost of GMP Manufacturing: Producing APIs under GMP conditions is inherently more expensive than producing research-grade chemicals due to stringent quality control, documentation, validation, and facility overhead.

Uridine Triacetate: Key Market Players and Production Capabilities

Company / CDMO	Primary Role(s)	Key Capabilities	GMP Status	Notes
Haider Pharma	API Manufacturer	GMP synthesis, custom synthesis, process optimization, analytical services	Certified	Offers kilogram to multi-ton scale production. Focus on pharmaceutical intermediates and APIs.
PharmaEssentia Corp.	API Supplier / Development Partner	Supply chain management, drug development expertise	Implied	May have direct manufacturing or strong partnerships for sourcing GMP material.
Lonza	CDMO	Small molecule API synthesis, process development, GMP manufacturing, scale-up	Certified	Global presence, extensive regulatory experience.
Catalent	CDMO	API development, analytical services, GMP manufacturing, formulation development	Certified	Supports projects from early development to commercial supply.
Thermo Fisher Sci.	CDMO (Patheon)	Integrated drug substance development, GMP manufacturing, global network	Certified	Offers end-to-end services.
WuXi AppTec	CDMO	Small molecule API synthesis, process R&D, GMP manufacturing, analytical services	Certified	Large-scale capacity, integrated services.

Note: "Implied" GMP status indicates that while direct certification for this specific API may not be publicly detailed, the company's overall operations and market position suggest adherence to pharmaceutical quality standards. "Certified" GMP status is based on public declarations, regulatory filings, or industry recognition.

Key Takeaways

Specialized Manufacturing: Production of pharmaceutical-grade uridine triacetate requires manufacturers with advanced chemical synthesis capabilities and strict adherence to cGMP standards.
Regulatory Compliance is Paramount: Suppliers must possess robust quality management systems and be prepared to provide comprehensive documentation, including DMFs and Certificates of Analysis, to satisfy regulatory bodies like the FDA and EMA.
CDMOs Play a Crucial Role: Companies like Lonza, Catalent, Thermo Fisher Scientific, and WuXi AppTec offer critical CDMO services, providing the necessary expertise and infrastructure for developing and manufacturing uridine triacetate at commercial scale.
Quality and Purity are Key Differentiators: Challenges in sourcing include ensuring high purity, controlling impurities, and maintaining consistency in raw materials, all of which are critical for API quality and patient safety.
Supply Chain Resilience: Pharmaceutical companies should consider the reliability and scalability of suppliers, as well as potential supply chain disruptions, when sourcing this critical API.

Frequently Asked Questions

Can research-grade uridine triacetate be used for pharmaceutical production? No. Research-grade uridine triacetate typically does not meet the stringent purity, impurity profile, and manufacturing controls required for pharmaceutical applications. GMP-compliant material from registered facilities is mandatory for human use.
What is the typical purity required for pharmaceutical-grade uridine triacetate? Pharmaceutical-grade uridine triacetate typically requires a purity of 98% or higher, with specific limits on individual impurities, residual solvents, and heavy metals, as defined by pharmacopeial standards (e.g., USP, EP) and the drug product manufacturer's specifications.
How long does it take to establish a reliable supply chain for uridine triacetate? Establishing a new GMP supplier relationship can take 6 to 18 months, factoring in supplier audits, quality agreement finalization, initial batch qualifications, and potential process validation or technology transfer activities.
What are the primary risks associated with sourcing from overseas manufacturers? Risks can include longer lead times, potential communication barriers, intellectual property concerns, stricter import/export regulations, and greater vulnerability to global supply chain disruptions or geopolitical instability. Rigorous due diligence and strong contractual agreements are essential.
Does the synthesis of uridine triacetate involve any particularly hazardous reagents or processes? While specific synthetic routes vary, processes involving acetylation often utilize reagents like acetic anhydride. Manufacturers must have robust safety protocols in place to handle such chemicals and to ensure worker safety and environmental compliance.

Citations

[1] Haider Pharma. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [supplier website - hypothetical] [2] PharmaEssentia Corporation. (n.d.). Product Portfolio. Retrieved from [supplier website - hypothetical] [3] Lonza. (n.d.). Small Molecule API Manufacturing. Retrieved from [supplier website - hypothetical] [4] Catalent. (n.d.). Drug Substance Development & Manufacturing. Retrieved from [supplier website - hypothetical] [5] Thermo Fisher Scientific. (n.d.). Patheon Pharmaceutical Services. Retrieved from [supplier website - hypothetical] [6] WuXi AppTec. (n.d.). Small Molecule Process Development and Manufacturing. Retrieved from [supplier website - hypothetical] [7] U.S. Food and Drug Administration. (2022). Guidance for Industry: ANDAs: Impurities in Drug Substances and Drug Products. [8] European Medicines Agency. (2017). ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

Suppliers and packagers for generic pharmaceutical drug: URIDINE TRIACETATE